Recall Z-1615-2012 ยท IQA System, Environmental Control, Powered
Intel-GE Care Innovations LLC
QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 (USA) and QCE200403, v.02; QCE200403, v.03 (UK). Manufacturer Living Independently Group, Inc., New York, NY. QuietCare is intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
| Date | May 16, 2012 (initiated Jul 30, 2011) |
| Status | Terminated |
| Reason | The QuietCare production system experienced a partial outage on 7/29/11. As a result of the partial outage, some monitoring data about residents' movements was not processed in the production system, and alerts were therefore not sent to caregivers. The problem was identified and corrected and the unprocessed data was recovered and processed. However, because of the time lag in processing, a fe |
| Root cause | Employee error |
| Action | Initial notification to the affected facilities was done by telephone or email on 7/30/11. This was followed up with Urgent Field Notification letters to the customers on 8/12/11 via e-mail. For questions, customers were instructed to contact Customer Support at 1 (866) 772-8243. |
| Quantity | 82 units affected by the outage: Domestic - 80 units, Foreign - 2 units |
| Distribution | Worldwide distribution - USA and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.